MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC REPLIFORM PUBOVAGINAL SLING MESH, SURGICAL, POLYMERIC

Catalog Number 820-244

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Chills (2191); Reaction (2414); Sweating (2444); Ambulation Difficulties (2544); Abdominal Distention (2601); Constipation (3274)

Event Date 09/24/2009

Event Type  Injury  

Event Description

On (b)(6) 2009, i was implanted with repliform tissue regeneration matrix, (lifecell - human dermis allograft) for incontinence. I was not informed as to what was implanted in me until years later when i put all my medical conditions together and realized i had been rejecting this tissue the whole time. I have suffered with rashes, allergies, chest pain, stomach pain, pelvis and right side severe pains to the point where i was unable to walk. It has affected my eyes, teeth, skin, intestines, liver, kidney, muscles, finger/toe nails, hair, you name it. It has affected my whole body. I have severe all over body pain and heat to the point of passing out from it. I be nauseated, sick on my stomach, get chills, headaches, constipation/ diarrhea, high fever, body sweats, and just feel week and very tired at all time. My abdomen stays distended. I have been to doctors and no one can help me. The doctors can put it in but can't remove it. Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC REPLIFORM PUBOVAGINAL SLING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11222585
• MDR Text Key: 228879725
• Report Number: MW5098952
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/24/2009
• Device Catalogue Number: 820-244
• Device Lot Number: B24783018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/22/2021 Patient Sequence Number: 1